Molecular Biomarkers in Renal Transplantation Via TruGraf® Test
- Conditions
- Kidney Transplant Rejection
- Registration Number
- NCT04398498
- Lead Sponsor
- Transplant Genomics, Inc.
- Brief Summary
The TruGraf® test is a non-invasive blood test that measures molecular gene expression profiles associated with clinical conditions previously only diagnosed by biopsy in kidney transplant recipients. The results of the TruGraf test provide additional information about the adequacy of immunosuppression and may be used to support decisions in patient management.
- Detailed Description
This is a single-center, prospective, randomized study to evaluate clinical utility of TruGraf testing in patients with the following characteristics:1.Stable serum creatinine: current serum creatinine \<2.3 mg/dl, \<20% increase compare to the average of the previous 3 serum creatinine levels2.Kidney transplant patients who are:•more than 60 days post-transplant will be included in this study (Study A) •more than 2-yearspost-transplant but less than 5 years post-transplant (\>24 months but \< 60 months) will be included in this study (Study B) Scripps will enroll subjects who are post-transplant and are undergoing routine management. In Study A, patients will receive testing eight times: Month 2 (at time of surveillance biopsy) 6(at time of surveillance biopsy), 9, 12(at time of surveillance biopsy), 15, 18, 21 and 24(at time of surveillance biopsy) (plus or minus two weeks). Results of the genomic analysis will be considered in determining patient treatment plans and as a molecular guide to perform a surveillance biopsy. Clinical data elements using the Scripps EHR and cost of care will be collected for all subjects. In Study B, patients who are at least 2 years post transplant up to 5 years post-transplant will receive testing 8 times: Months 3 ,6, 9, 12, 15, 18, 21 and 24 (plus or minus two weeks)from the time of enrollment into the study. Results of the genomic analysis will be considered in determining patient treatment plans and whether any change is needed, such as whether to perform a surveillance biopsy. Clinical data elements using the Scripps EHR and cost of care will be collected for all subjects. We expect Study A to be completed 24-30months and Study B to be completed in 24-30 months.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
- Recipient of a primary or subsequent deceased-donor or living donor kidney transplantation.
- Stable serum creatinine (current serum creatinine <2.3 mg/dl, <20% increase compared to the average of the previous 3 serum creatinine levels).
- Kidney transplant patients who are: > 60 days post-transplant (Cohort A); > 2-years post-transplant (Cohort B)
- Need for combined organ transplantation with an extra-renal organ and/or islet cell transplant.
- Recipients of previous non-renal solid organ and/or islet cell transplantation.
- Infection with HIV.
- Infection with BK.
- Patients that have nephritic proteinuria (urine protein >3 gm/day).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cohort A and B: Banff pathology 2 years Banff pathology will be assessed and compared to TruGraf results.
Cohort A: Percent or total number of patients who physicians decided could forego a surveillance biopsy due to TruGraf results 24 months post-transplant Cohort A: Correlation of TruGraf test results with surveillance biopsy 2 years Cohort A and B: Renal graft function 2 years Renal graft function will be assessed by measuring serum creatinine (sCr) levels.
Cohort A and B: Cost of patient care 2 years The cost of patient care will be evaluated by measuring the total health care spending for health care services provided during the study period.
- Secondary Outcome Measures
Name Time Method Incidence of death 2 years Incidence of graft loss 2 years
Trial Locations
- Locations (1)
Scripps Clinic
🇺🇸La Jolla, California, United States